Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Acronym

Study hypothesis

1. To demonstrate clinically significant improvements in the spinal endoscopy with adhesiolysis patients compared to those patients randomized to the control group who did not receive spinal endoscopy therapy, but received epidural injections. Improvement will be assessed in relation to the clinical outcome measures of pain and function.2. To evaluate and compare the adverse event profile in both groups

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic low back pain and lower extremity pain

Intervention

Spinal endoscopy with adhesiolysis using Myeloscope® (Visionary Biomedical Inc)Epidural local anesthetic with steroid

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To demonstrate a clinically significant difference between the treated patients and those patients randomized to the control group in the Physical Function and Pain at 1, 3, 6 and 12 months post treatment

Secondary outcome measures

To assess adverse events in both groups

Overall trial start date

23/01/2002

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Candidate is between 18 and 65 years of age2. Subjects with a history of chronic, function limiting low back pain of at least six months in duration3. Subjects who are able to give voluntary, written informed consent to participate in this investigation4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the clinic for all the required post-operative follow-ups5. The subject has not had recent surgical procedures within the last three months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Maximum 100 patients total - Study included total of 83 patients

Participant exclusion criteria

1. Large contained or sequestered herniation. A small contained herniation is permitted (<4 mm).2. Cauda Equina symptoms and/or compressive radiculopathy3. Narcotic use of no greater than Hydrocodone 100 mg/day, Methadone of 60 mg or Morphine 100 mg, or dose equivalent4. Uncontrolled major depression or uncontrolled psychiatric disorders5. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, history of gastrointestinal bleeding or ulcers, urinary sphincter dysfunction, progressive neurological deficit, infection, increased intracranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease6. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function7. Women who are pregnant or lactating8. Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment9. Patients with multiple complaints involving hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints10. Inability to achieve appropriate positioning and inability to understand informed consent and protocol11. History of adverse reaction to local anesthetic or anti-inflammatory drugs or history of gastrointestinal bleeding or ulcers

Recruitment start date

23/01/2002

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United States of America

Trial participating centre

2831 Lone Oak Road
Paducah, KY
42003
United States of America

Sponsor information

Organisation

Institutional Review Board of Ambulatory Surgery Center (USA)

Sponsor details

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

The Myeloscope® Spinal Endoscopy Introducer and Video-Guided Catheter System used in this study were provided by Clarus Medical Systems, Inc. No other external support or funding were received in completion of this study.